This role is designed to be 100% onsite, giving you the opportunity to collaborate closely with your team and immerse yourself in the energy of our workplace. Please note that hybrid or remote work options are NOT available for this position at this time.

Within ACRO, the Clinical Coordinating Center (CCC) offers infrastructure and expertise for investigator-initiated trials (IITs) and collaborative, multi-site clinical research. The CCC Clinical Research Specialist II will serve in a cross-functional role and interface with internal and external stakeholders to coordinate all aspects of assigned investigator-initiated and multi-site projects.

The Clinical Research Specialist II provides clinical research expertise by participating in the design and implementation of research projects as needed. Responsible for specific and assigned aspects of research infrastructure development, coordinates projects, and communicates status and improvement areas to leadership. May implement and coordinate department-wide initiatives such as research quality management or clinical trial recruitment efforts. Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board (IRB).

Primary Duties and Responsibilities

• Provides research writing activities such as developing scientific documents for abstracts, publications, presentations, funding applications, and study protocols.
• Serves as an internal advisor for specific departmental activities.
• Provides guidance regarding project planning, project logistics, and project implementation.
• Provides clinical research expertise by participating in the design and implementation of research projects as needed by the department or institution.
• Responsible for specific and assigned aspects of research infrastructure development and/or maintenance.
• Coordinates research projects at an institutional or departmental level.
• Communicates project status and improvement areas with leadership in a timely manner.
• Projects may include, but are not limited to investigator-initiated protocol development including protocol writing, case report form development, budget development, and coordination of departmental research committees.
• May implement and coordinate department-wide initiatives such as research quality management or clinical trial recruitment efforts.
• Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board.
• Maintains research practices using Good Clinical Practice (GCP) guidelines.
• Maintains strict patient confidentiality according to HIPAA regulations and applicable law.
• Participates in required training and education programs.

This role is designed to be 100% onsite, giving you the opportunity to collaborate closely with your team and immerse yourself in the energy of our workplace. Please note that hybrid or remote work options are NOT available for this position at this time.

Requirements:

• Bachelor's Degree required.
• 5 years of experience in clinical research, regulatory, or data coordination required.
• Experience with investigator-initiated and/or multisite research preferred.
• ACRP/ SOCRA (or equivalent) certification preferred.

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